A pharmaceutical company needs to conduct a clinical trial for a newly developed drug and apply for an approval by attaching a Case Report Form (CRF) that indicates the result of the clinical trial in order to obtain the approval by the government for manufacturing and distributing the newly developed drug (hereinafter described as “new drug”).
A pharmaceutical company requests medical institutions such as hospitals to conduct a clinical trial. A physician who works for the medical institution that received the request conducts the clinical trial, creates CRFs to submit to the pharmaceutical company. Recently, Electronic Data Capture (EDC) systems have been used for capturing CRFs as electronic data, “electronic CRFs.” Japanese Laid-open Patent Publication No. 2004-220599 discusses an example of an EDC.
The pharmaceutical company checks a CRF against the original document to determine whether any error entry exists. The check task is called Source Document Verification or Source Data Verification. Alternatively, the check task is simply called SDV.
An error entry in the CRF needs to be corrected by a physician. If the physician is informed about the error entry and a correct value by the pharmaceutical company, the physician can easily correct the error entry without referring to the original document.
However, the above-described correction method is not always preferable. This is because that a result of the SDV by the pharmaceutical company may be wrong. Moreover, the pharmaceutical company may inform an incorrect value with an intention or negligence even if the pharmaceutical company found an error entry in the CRF.
Accordingly, the physician needs to check the original document against the CRF and correct the CRF without being informed about a correct value from the pharmaceutical company. An amount of original documents is enormous, and the correction task is a heavy burden on the physician.
Accordingly, improving accuracies to create a CRF is considered. For example, a physician, an examination engineer, or a subject enters each item that makes up a form using an electronic pen. A server identifies original data entered in each item by the user, based on entry data acquired through the electronic pen. The server then compares the identified original data with essential data for creating the case report form and determines whether there is any omission in entry. When it is determined that there is an omission in entry, the server prepares a warning message to the effect and transmits the message to a terminal device which transmitted the entry data. When it is determined that there is no omission in entry, the server creates the case report form based on the identified original data (for example, Japanese Laid-open Patent Publication No. 2006-323486).
Moreover, a method to check correctness may be considered in which two operators input data for each item separately, and the input two units of data are compared (for example, Japanese Laid-open Patent Publication No. 11-31041).
In order to compare a CRF with the original data by a computer such as a server, the original data needs to be electronic data. However, a document that becomes original data, for example, a medical record is still written in a paper form.
Furthermore, according to the method in which each data is input by two operators, two physicians have to input a CRF. Thus, burdens on the physicians become significant. According to the method, a CRF may not be input correctly by only one physician.